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NCT04627428 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
A Phase 1 study of Dry Age-Related Macular Degeneration, sponsored by Luxa Biotechnology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT04627428: Recruiting Phase 1 study of Dry Age-Related Macular Degeneration, sponsored by Luxa Biotechnology.
NCT04627428 is a Phase 1 study of Dry Age-Related Macular Degeneration that is actively recruiting participants, run by Luxa Biotechnology. The registered enrollment target is 18 participants, below the 81-participant average among 7 other Dry Age-Related Macular Degeneration trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04627428, a Phase 1 study of Dry Age-Related Macular Degeneration, is actively recruiting participants, sponsored by Luxa Biotechnology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study Summary
The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Primary Outcome
The transplantation of RPESC-RPE-4W cells will be considered safe and tolerated in the absence of: * Decrease in visual acuity (VA) of more than 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (or to worse than counting fingers at three feet) from baseline * Any Grade 2 (CTCAE v5.0) or greater non-ocular Adverse Events (AE) related to the RPESC-RPE-4W investigational product (IP) or investigational interventions * Intraocular inflammation indicating contamination with an infectiou
Conditions Studied
Interventions
- BIOLOGICAL RPESC-RPE-4W
Study Locations (3)
California
- Retina Vitreous Associates Medical Group - Beverly Hills
- Spencer Center for Vision Research - Palo Alto
Michigan
- University of Michigan Kellogg Eye Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-04-05 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
What NCT04627428 shows while recruiting
NCT04627428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 81-participant average among 7 other Dry Age-Related Macular Degeneration trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Dry Age-Related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which RPESC-RPE-4W is the first listed.
NCT04627428 reports a single indexed study location in California, Michigan.
Frequently Asked Questions
What is clinical trial NCT04627428 about?
NCT04627428 is a clinical study titled "Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)". The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
What is the current status of trial NCT04627428?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-04-05. Estimated completion is 2026-12-01.
What conditions does trial NCT04627428 study?
This clinical trial studies the following conditions: Dry Age-Related Macular Degeneration.
What interventions are being tested in trial NCT04627428?
The interventions under investigation include: RPESC-RPE-4W (BIOLOGICAL).
Who is sponsoring clinical trial NCT04627428?
This trial is sponsored by Luxa Biotechnology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04627428 being conducted?
This trial has 3 study locations across California, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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